Side lumen reentry catheters and related methods

Abstract

True lumen reentry devices and methods useable for redirecting a guidewire from a subintimal tract within a wall of a blood vessel into the true lumen of the blood vessel. A reentry catheter device comprises a main catheter shaft having at least one guidewire outlet aperture with at least one side tube located on a distal portion of the main catheter shaft. The side tube(s) is/are tracked over initially inserted guidewire(s) to advance a distal portion of the reentry catheter device into the subintimal tract with a guidewire.

What is claimed is:  
     
       1. A blood vessel lumen reentry device comprising:
 a catheter having a distal end, a right side, a left side, a top side and a bottom side; 
 a first guidewire exit port located in the bottom side of the catheter a spaced distance from its distal end; 
 a second guidewire exit port located in the top side of the catheter a spaced distance from its distal end; 
 a lumen extending from the distal end of the catheter to at least the first and second guidewire exit ports; 
 a rotational orientation indicator useable for determining the rotational position of the guidewire exit port when positioned within the blood vessel of a human or animal subject; 
 a side tube on either the right or left side of the catheter adjacent to the first and second guidewire exit ports, said side tube having a proximal end opening, a through lumen and a distal end opening. 
 
     
     
       2. A device according to  claim 1  wherein the distal end of the catheter is closed. 
     
     
       3. A device according to  claim 1  wherein the rotational orientation indicator comprises a marker which, when imaged by an imaging device, provides an indication of the rotational position of the guidewire exit port. 
     
     
       4. A method for using a reentry device according to  claim 1  to facilitate bypassing an obstruction in a blood vessel that has a true lumen and a blood vessel wall, said method comprising the steps of:
 advancing a first guidewire, which has a proximal end and a distal end, through the lumen of the blood vessel proximal to the obstruction and into the blood vessel wall adjacent to the obstruction so as to create a subintimal tract which is separate from the true lumen of the blood vessel, said subintimal tract extending past the obstruction and the distal end of the first guidewire being positioned within the subintimal tract at a location distal to the obstruction; 
 inserting the proximal end of the first guidewire into the distal end opening of the side tube and advancing the device of  claim 1  over the first guidewire and into the subintimal tract to a location where the guidewire exit port is located distal to the obstruction; 
 using the rotational orientation indicator to determine the rotational position of the guidewire exit port within the subintimal space; 
 adjusting the rotational orientation of the reentry device, if necessary, to cause the guidewire exit port to be directed toward the true lumen of the blood vessel; 
 advancing a second guidewire through the lumen of the catheter, out of the guidewire exit port and into the true lumen of the blood vessel, distal to the obstruction; 
 removing the first guidewire and the reentry device, leaving the second guidewire in place such that the second guidewire extends through the true lumen proximal to the obstruction, through the subintimal tract and back into the true lumen distal to the instruction; and 
 advancing one or more working devices over the second guidewire to dilate the subintimal tract thereby creating a blood flow channel around the obstruction. 
 
     
     
       5. A method for using a reentry device according to  claim 1  to facilitate bypassing an obstruction in a blood vessel that has a true lumen and a blood vessel wall, said method comprising the steps of:
 loading a distal portion of a first guidewire into the side tube and advancing the device of  claim 1  through the lumen of the blood vessel proximal of the obstruction; 
 advancing the first guidewire into a subintimal tract created within the wall of the blood vessel, said subintimal tract being separate from the true lumen of the blood vessel and extending past the obstruction, and advancing the reentry device over the first guidewire to a location where its guidewire exit port is located distal to the obstruction; 
 using the rotational orientation indicator to determine the rotational position of the guidewire exit port within the subintimal space; 
 adjusting the rotational orientation of the reentry device, if necessary, to cause the guidewire exit port to be directed toward the true lumen of the blood vessel; 
 advancing a second guidewire through the lumen of the catheter, out of the guidewire exit port and into the true lumen of the blood vessel, distal to the obstruction; 
 removing the first guidewire that is positioned within the subintimal tract and the reentry device, leaving the second guidewire in place such that the second guidewire extends through the true lumen proximal to the obstruction, through the subintimal tract around the obstruction and back into the true lumen distal to the instruction; and 
 advancing one or more working devices over the second guidewire to dilate the subintimal tract thereby creating a blood flow channel around the obstruction. 
 
     
     
       6. A method according to  claim 5  wherein the obstruction is a chronic total obstruction. 
     
     
       7. A method according to  claim 5  wherein said at least one working device comprises a balloon for dilating the subintimal tract. 
     
     
       8. A method according to  claim 7  wherein said at least one working device further comprises a stent for stenting the dilated subintimal tract. 
     
     
       9. A blood vessel lumen reentry device comprising:
 a catheter having a distal end, a right side, a left side, a top side and a bottom side; 
 a lumen extending through the catheter; 
 a first guidewire exit port located in the top side of the catheter a spaced distance from its distal end; 
 a second guidewire exit port located in the bottom side of the catheter a spaced distance from its distal end; 
 a rotational orientation indicator useable for determining the rotational positions of the first and second guidewire exit ports when positioned within a blood vessel of a human or animal subject; 
 a first side tube attached to the right side of the catheter adjacent to the first and second exit ports, said first side tube having a proximal end opening, a through lumen and a distal end opening; and 
 a second side tube attached to the left side of the catheter adjacent to the first and second exit ports, said second side tube having a proximal end opening, a through lumen and a distal end opening. 
 
     
     
       10. A device according to  claim 9  wherein the rotational orientation indicator comprises a marker which, when imaged by an imaging device, provides an indication of the rotational positions of the first and second guidewire exit ports. 
     
     
       11. A device according to  claim 9  wherein the first and second guidewire exit ports are at longitudinally spaced-apart locations. 
     
     
       12. A device according to  claim 9  wherein the distal end of the catheter is closed. 
     
     
       13. A device according to  claim 9  wherein the rotational orientation indicator comprises a marker which, when imaged by an imaging device, provides an indication of rotational positions of the first and second guidewire exit ports. 
     
     
       14. A method for using a reentry device according to  claim 13  to facilitate bypassing an of an obstruction in a blood vessel that has a true lumen and a blood vessel wall, said method comprising the steps of:
 causing a first guidewire and a second guidewire to extend through the true lumen of the blood vessel proximal to the obstruction and to create a subintimal tract within the wall of the blood vessel, said subintimal tract being separate from the true lumen of the blood vessel and extending past the obstruction; 
 advancing the reentry device, with the first and second side tubes tracking over the first and second guidewires respectively, to a location where the first and second guidewire exit ports are located within the subintimal tract distal to the obstruction; 
 using the rotational orientation indicator to determine which of the first and second guidewire exit ports is directed toward the true lumen of the blood vessel; 
 advancing a third guidewire through the lumen of the catheter, out of whichever guidewire exit port is determined to be directed toward the true lumen of the blood vessel and into the true lumen of the blood vessel, distal to the obstruction; 
 removing the first guidewire, the second guidewire and the reentry device, leaving the third guidewire in place such that the third guidewire extends through the true lumen proximal to the obstruction, through the subintimal tract, and back into the true lumen distal to the instruction; and 
 advancing one or more working devices over the third guidewire to dilate the subintimal tract thereby creating a blood flow channel around the obstruction. 
 
     
     
       15. A method according to  claim 14  wherein the first guidewire was used to create the subintimal tract and then allowed to remain within the subintimal tract. 
     
     
       16. A method according to  claim 14  wherein:
 after the first and second guidewires have been advanced into the subintimal tract, the proximal ends of the first and second guidewires are inserted into the distal end openings of the first and second side tubes of the reentry device; and 
 the reentry device is then advanced, with the first and second side tubes tracking over the first and second guidewires, to said location within the subintimal tract. 
 
     
     
       17. A method according to  claim 14  wherein:
 after the first guidewire has been advanced into the subintimal tract, the proximal end of the first guidewire is inserted into the distal end opening of the first side tube; 
 the distal end of the second guidewire is inserted into the proximal end opening of the second side tube; 
 the reentry device and second guidewire are advanced, with the first side tube tracking over the first guidewire, to a location near the location at which the first guidewire enters the subintimal tract; 
 the second guidewire is then advanced through the second side tube and into the subintimal tract along side the first guidewire; and 
 the reentry device is then further advanced, with the first and second side tubes tracking over the first and second guidewires, to said location within the subintimal tract. 
 
     
     
       18. A method according to  claim 14  wherein the obstruction is a chronic total obstruction. 
     
     
       19. A method according to  claim 14  wherein said at least one working device comprises a balloon for dilating the subintimal tract. 
     
     
       20. A method according to  claim 19  wherein said at least one working device further comprises a stent for stenting the dilated subintimal tract. 
     
     
       21. A blood vessel lumen reentry device comprising:
 a catheter having a distal end and a side wall; 
 a first guidewire exit port formed at a first location in the side wall of the catheter a spaced distance from its distal end; 
 a second guidewire exit port formed at a second location in the side wall of the catheter a spaced distance from its distal end; 
 a lumen extending from the distal end of the catheter to at least the guidewire exit port; 
 a rotational orientation indicator useable for determining the rotational position of the guidewire exit port when positioned within the blood vessel of a human or animal subject; 
 a side tube extending along a portion of the catheter side wall such that the first guidewire exit port is located above the side tube and the second guidewire exit port is located below the side tube, said side tube having a proximal end opening, a through lumen and a distal end opening.